Director of R&D QA (GCP Compliance)
An innovative & stable gene therapy biotech is looking to bring on a Director-level GCP expert to join its growing team. This company has proven itself to be one of the fastest growing biotechs in genetic therapy technology, and has more than doubled in headcount over the last 2 years.
- Execution and administration of the GCP Quality System compliant with ICH, US and EU regulations
- All aspects of GCP Compliance, from strategic planning to hands-on implementation
- Identify risks and suggest mitigation plans related to assigned projects
- Lead preparations for and management of any Regulatory Agency inspections
- Provide leadership & mentorship to the organization
- Collaborate with Supplier Quality to determine appropriate vendor use
- Review and approve responses and corrective actions related to audit activities and reports.
- Plan & oversee day-to-day activities of the GCP Compliance including management of consultants/auditors as needed, to ensure project & business needs are met
The ideal candidate will have the following skill set:
- 10 years of experience in the pharmaceutical, device or diagnostic industry with at least 7 of those years in GCP Compliance
- BA/BS (or higher) in a scientific discipline or equivalent combination of education and experience is required.
- Strong communication and collaboration skills